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NEWSLETTER
Regulatory Newsletter
Edition 2
Welcome to the second edition of the regulatory newsletter, your trusted source for the latest developments, trends, and analysis in the ever-evolving regulatory landscape.
Our team of seasoned regulatory professionals and industry experts meticulously curate content to address the most pressing issues faced by professionals. We delve into topics such as regulatory compliance, quality assurance, clinical trials, post-market surveillance, labeling requirements, regulatory submissions, and many others.
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Industry Updates
Job cuts at Thermo Fisher, Abbott Laboratories, and Cook Medical; Expansion by Dexcom and Boston Scientific in Ireland; Change in CFO for GE Healthcare.
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As a result of the anticipated decrease in demand for Covid testing products, Thermo Fisher plan to cut a further 218 jobs and close 3 facilities in California, and Abbott Laboratories are cutting 199 jobs at their facility in Maine.
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Cook Medical have announced that 500 jobs will be cut as part of the implementation plan of the company's long term strategy. It was confirmed that the redundancies will not affect hourly manufacturing or distribution center employees as product demand is continuing to grow. The announcement was made via an email available on the Cook website, by the company president Pete Yonkman.
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Dexcom have announced that they will build their first European manufacturing site in Galway, with the creation of 1,000 jobs over the next 5 years. The site will manufacture glucose monitors.
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Boston Scientific have announced an €80 million investment in their Clonmel site, with the creation of more than 400 jobs. The investment will lead to the expansion of their existing manufacturing and R&D facilities where defibrillators and implantable pacemakers are produced, among other devices.
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An announcement by Baxter has confirmed that former CFO, Jay Saccaro has been hired by GE HealthCare in the same role, starting on 1st June.
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Europe Updates
Information requested to assist in the update of SCHEER guidance on the use of phthalates in medical devices; Experts call for more IVDR specific guidance; Update to MDCG 2020-3; Release of manufacturer/notified body agreement template; New CI report guidance.
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The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) are required to update their guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices by June 2024. These guidelines are particularly important for manufacturers to whom MDR GSPR 10.4 is applicable. As such any information that could assist the scientific committee with their assessment and the update of the guideline, is requested and submission of this information is welcomed until 17th July 2023.
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At the RAPS Euro Convergence, held on 12th May, a panel of IVD experts from different notified bodies highlighted the requirement for more IVDR specific guidance during the transition period. Much of the MDCG guidance that has been released thus far deals primarily with MDR and while these documents can be useful for IVDR, more specific guidance would ultimately help to speed up the review process for both manufacturers and notified bodies alike. It was also noted that there has been a decline in the number of submissions since the deadline extension, and manufacturers are encouraged to submit files as early as possible to avoid a future bottleneck.
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Team NB have released a template for a confirmation letter that a notified body and a manufacturer have a written agreement in place regarding Regulation EU 2023/607 amending MDR and IVDR.
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MDCG has released an update to their original 2020 document, "Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD". This update is intended to align the guidance document with Regulation (EU) 2023/607 and MDCG guidance 2022-2.
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The European Commission has released guidance on the content and structure of the summary of the clinical investigation report, as required by MDR.
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MHRA Updates
New guidance on SaMD vigilance; Updates to guidance documents on software applications, and device registration.
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MHRA have released guidance for manufacturers on reporting adverse incidents involving software as a medical device under the vigilance system. The guidance provides examples of types of harm, types of adverse incidents, and how these incidents should be reported.
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An update has been made to MHRA guidance on software applications, and when these apps are considered to be a medical device. This revision includes an update to the 'Medical device stand-alone software including apps' file, to include information on the implementation of new regulations, updates to various links including MORE and the new software vigilance guidance.
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MHRA have released an update to their guidance document on how to register medical devices to place on the market. This revision includes the addition of new video tutorials, and updates to the reference guides.
FDA Updates
Draft guidance released on decentralized clinical trials
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FDA has released a draft guidance document on Decentralized Clinical Trials for Drugs, Biological Products, and Devices. The guidance is intended for all trial stakeholders, where a clinical trial is being partially or fully conducted at non-traditional trial locations. Comments are welcomed until 1st August 2023.
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Australia Updates
TGA recognizes MDR transition extension
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TGA have confirmed that they will recognise the recently announced transition extension for the EU MDR, and will continue to accept MDD certificates according to the new provisions of that extension.
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AI & Cybersecurity News
WHO call for caution in the use of AI
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WHO has called for caution to be exercised in the use of AI as a decision support tool in a medical capacity. The key concerns have been summarised in an article along with a proposal that clear evidence of any benefits should be measured before the tool is rolled out for widespread use in healthcare settings.
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